UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042031
Receipt number R000047972
Scientific Title Vascular endothelial disorders and surgical site infection (abdominal surgery)
Date of disclosure of the study information 2020/10/08
Last modified on 2020/10/07 09:22:40

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Basic information

Public title

Vascular endothelial disorders and surgical site infection (abdominal surgery)

Acronym

Vascular endothelial disorders and surgical site infection (abdominal surgery)

Scientific Title

Vascular endothelial disorders and surgical site infection (abdominal surgery)

Scientific Title:Acronym

Vascular endothelial disorders and surgical site infection (abdominal surgery)

Region

Japan


Condition

Condition

abdominal surgery

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Monitoring tcpO2 in perioerative period

Basic objectives2

Others

Basic objectives -Others

Measuring endothelial microparticles in perioerative period

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

tcpO2 in perioperative period

Key secondary outcomes

endothelial microparticles in perioperative period


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who were over twenty years of age, scheduled to undergo an open surgery with ASA-PS classification of 1 to 3

Key exclusion criteria

Patients with respiratory failure (PaO2 / FIO2<200), under mechanical ventilation, with dermatosis, under immunosuppressive condition, during sepsis, underwent emergency operation and previously participated in this study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Takanori
Middle name
Last name Aihara

Organization

Tohoku University Hospital

Division name

Anesthesiology

Zip code

9808574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan

TEL

022-717-7321

Email

taka.vxiv@gmail.com


Public contact

Name of contact person

1st name Takanori
Middle name
Last name Aihara

Organization

Tohoku University Hospital

Division name

Anesthesiology

Zip code

9808574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan

TEL

022-717-7321

Homepage URL


Email

taka.vxiv@gmail.com


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Tohoku University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

MHLW Certified Clinical Research Review Board, Tohoku University

Address

2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan

Tel

022-718-0461

Email

office@nrs.hosp.tohoku.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 08 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

120

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2017 Year 01 Month 10 Day

Date of IRB

2018 Year 04 Month 09 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Monitoring tcpO2 in perioperative period and measuring endothelial microparticles.
Verifying the relationship between SSI and peripheral circulation.


Management information

Registered date

2020 Year 10 Month 07 Day

Last modified on

2020 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047972


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name